Kornimate/medical-research-clean huggingface dataset:
ten-year outcomes after af ablation

Conditions: Atrial Fibrillation

Summary: ablation of atrial fibrillation (af) using pulmonary vein isolation is employed when patients do not respond favorably to medical therapy. successful procedures are accomplished in the majority of patients, but the outcome after many years of follow-up after ablation is unknown.

a prospectively identified cohort of 445 patients who demonstrated freedom from af for at least one year following ablation (single procedure in 391, 87.9%) was followed for 66.0 ± 34.0 months. patients were seen at least annually as outpatients, and underwent regular ecg monitoring, especially if there were symptoms suggestive of recurrent arrhythmia. continued absence of arrhythmia was defined as freedom from af or flutter \> 30 secs.

Eligibility criteria:
inclusion criteria: * prior af ablation procedure * no af for one year post ablation exclusion criteria: * geographic inaccessibility * longstanding persistent af * recurrent af within one year of ablation * prior af ablation
effects of postbiotics on mood disorders in korean adults

Conditions: Mood Disorder

Summary: this study was conducted to investigate effects of postbiotics on mood disorders in korean adults

this study is an 8-week, randomized, double-blind, placebo-controlled, parallel-group clinical trial. 52 participants were randomly assigned to either the postbiotics intervention group or a placebo group. the study aimed to evaluate the effects of postbiotics on mood disorders in korean adults, comparing pre- and post-intervention mood profiles.

Eligibility criteria:
inclusion criteria: * adults aged between 19 and 39 years at the time of screening. * bmi between 18.5 and 30 at the time of screening. * ces-d (center for epidemiologic studies depression scale) score of 16 or higher. * ability to access and respond to the survey via an online link. exclusion criteria: * participation in any human clinical trial within the past 3 months before screening. * history of antipsychotic medication treatment within the past 3 months before screening. * presence of chronic diseases, including cardiovascular, endocrine, immune, respiratory, hepatobiliary, renal and urological, neurological, musculoskeletal, inflammatory, hematological, oncological, or gastrointestinal disorders. * use of medications or health supplements related to gut health and mood disorders (e.g., antibiotics, laxatives, antidiarrheals, prebiotics, probiotics, postbiotics, anxiolytics, antidepressants, etc.) within 1 month prior to participation in the study. * history of significant hypersensitivity to postbiotics or starch. * alcohol addiction, drug abuse, or suspicion of substance misuse. * pregnant or breastfeeding women. * any other reasons that the study investigator deems the participant unsuitable for participation.

Keywords: mood disorder postbiotics
a patient registry study for patients treated with voretigene neparvovec in us

Conditions: Confirmed Biallelic RPE65 Mutation-associated Retinal Dystrophy

Summary: the objective of this study is to collect long-term safety information (i.e., for 5 years after treatment) associated with voretigene neparvovec-rzyl (vector and/or transgene), its subretinal injection procedure, the concomitant use of corticosteroids, or a combination of these procedures and products. the enrollment period will last for two years from the first treatment following product approval (through 31march2020) and include a minimum of 40 patients.

voretigene neparvovec-rzyl is a gene therapy intended for use in individuals with confirmed biallelic rpe65 mutation-associated retinal dystrophy and viable retinal cells. mutations in the rpe65 gene are associated with several clinical manifestations including nyctalopia, decreased visual field and decreased visual acuity. voretigene neparvovec-rzyl uses a non-pathogenic recombinant adeno-associated virus vector serotype 2 (aav2) to deliver cdna encoding rpe65 protein to target cells in the retina. voretigene neparvovec-rzyl is administered to each eye via subretinal injection. the administration of voretigene neparvovec-rzyl is recommended to be performed to each eye on separate days within a close interval. prescribing information recommends an immunomodulatory regimen concomitant with administration, with the actual regimen dependent upon the dosing center. this post authorization safety study will focus on further characterizing the long-term safety profile of voretigene neparvovec-rzyl in patients with rpe65 mutation-associated retinal dystrophy using an observational, longitudinal design.

Eligibility criteria:
inclusion criteria: 1. received voretigene neparvovec-rzyl in at least one eye. 2. signed informed consent/assent (when applicable). these are obtained as required under institutional policies and applicable laws and regulations unless a consent waiver is obtained from the institutional review board (irb)/independent ethics committee (iec). exclusion criteria: 1. previously participated in, or are currently participating in, a spark therapeutics clinical trial and received voretigene neparvovec-rzyl in both eyes.

Keywords: leber congenital amaurosis (lca) inherited retinal dystrophy rpe65 retinitis pigmentosa (rp)
safety of splenic stimulation for ra

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (nvb) with the galvani system, which consists of a lead, implantable pulse generator, external components and accessories. participants eligible for implant will have active rheumatoid arthritis (ra) and have an inadequate response or intolerance to at least two biologic disease modifying anti-rheumatic drugs (dmards) or jak inhibitors (jakis). five participants will be implanted with the device and receive neurostimulation for 12 weeks.

the study will be an open-label single-arm study to evaluate the safety and tolerability of galvani's neuromodulation system. participants with active rheumatoid arthritis (ra) will be implanted with the galvani system and receive active stimulation for 12 weeks. the total study duration in the study for each participant is approximately 5 months, with a 4-week screening period, 4 weeks recovery from surgery and a 12-week 'treatment' period. the participants will return to the clinic on pre-defined days for follow-up visits during the trial period. at days 42 and/or day 56, if study participants are not responding to stimulation, stimulation parameters might be adapted. at the end of the study (day-84), participants will enroll in a long-term follow-up study up to 5-years after enrollment in this study.

Eligibility criteria:
inclusion criteria: * adult-onset ra of at least six months duration * male or female participants, 22-75 years of age * active ra * inadequate response to at least 2 biologic dmards and/or jak- inhibitors (jakis) * have an appropriate washout from previously used biological dmards or jaki * a female participant should have no child-bearing potential exclusion criteria: * inability to provide informed consent. * significant psychiatric disease or substance abuse. * history of unilateral or bilateral vagotomy. * active or latent tuberculosis * known infection with human immunodeficiency virus (hiv); current acute or chronic hepatitis b or hepatitis c; previous hepatitis b. * currently implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators). * previous splenectomy * any investigational small molecule drug or biological within 2 weeks or 2 half-lives whichever is longer, before surgery. * uncontrolled other inflammatory diseases * current/recurrent infections that in the opinion of the pi risk\>benefit. * history of cancer within the past 5 years, except non-malignant skin cancer. * chronic use of morphine or oxicodone

Keywords: electrical stimulation inflammation active implantable medical device laparoscopy antirheumatic agents autonomic nervous system feasibility studies
efficacy of evonail® solution in the prevention of nail damage induced by docetaxel in patients with breast cancer.

Conditions: Breast Carcinoma

Summary: docetaxel is widely used in oncology for the treatment of many solid tumors. the side effects of docetaxel are many and sometimes serious. the primary toxicity of docetaxel is neutropenia. skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events. use of the product evonail® was demonstrated in a patient treated by doxetaxel and having nail damage. the purpose of this study is to confirm the effectiveness of the film-forming solution evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patient with breast carcinoma * patients treated with adjuvant chemotherapy (fec + 3 docetaxel +/- herceptin®) * patients who have never been treated with taxanes * patients with no nail damage before starting the study * ecog performance \< 2 * ability to provide written informed consent exclusion criteria: * patient allergic to any of the treatment components * use of film-forming solution, solvents or any other products applied to the fingernails (artificial nails ...) in three weeks before the first of docetaxel treatment * risk of exposure to aggressive factors nail during the study * using refrigerants gloves during chemotherapy treatments * onychophagia * presence of nail disease or a history of nail pathology (infectious and other) * pregnant or breast feeding females * patients whose condition is not compatible with the follow-up study

Keywords: chemotherapy neoadjuvant
diaphragm pacing in individuals with spinal cord injuries

Conditions: Cervical Spinal Cord Injury

Summary: this project will evaluate the effects of intramuscular diaphragm stimulation (pacing) and test the hypothesis that diaphragm pacing enhances neuromuscular diaphragm activation and respiratory function in adults with cervical spinal cord injuries (c-scis). the investigators will test the hypothesis by recording activity of the diaphragm from intramuscular pacing electrodes and conduct respiratory assessments in adults with intramuscular diaphragm pacing electrodes following acute, traumatic c-scis.

respiratory dysfunction is a leading cause of death in individuals with spinal cord injuries (scis). nearly one-quarter of all sci cases involve injury to the upper spinal cord segments which impairs neural activation of the diaphragm muscle and compromises breathing. although mechanical ventilation can be life-saving after cervical sci (c-sci), it also triggers rapid and profound diaphragm muscle atrophy, thereby complicating (or even preventing) ventilator weaning. intramuscular diaphragm stimulation, or diaphragm pacing, was developed to replace long-term ventilator support and is now used acutely post c-sci (\<4 months following injury) to promote ventilator weaning. this study will assess the effects of diaphragm stimulation on respiratory neural drive and breathing function in individuals with acute, traumatic c-sci. recording from these surgically implanted electrodes allows comparisons of electromyogram (emg) recordings, in association with respiratory assessments, before and after short periods of diaphragm pacing to isolate the unique contribution of diaphragm pacing on neuromuscular diaphragm activation.

Eligibility criteria:
inclusion criteria: * acute, traumatic cervical spinal cord injuries (c-scis), classified according to the american spinal injury association (asia) impairment scale (ais) as a-c * scheduled to undergo implantation of a diaphragm pacer, or who have recently received (in past 5-days) implantation of intramuscular diaphragm pacing electrodes due to severe respiratory impairments and dependence on mechanical ventilation exclusion criteria: * progressive neuromuscular diseases such as multiple sclerosis and myasthenia gravis * history of neurologic injuries such as stroke or prior sci * chest wall injuries or deformities likely to influence breathing * pregnancy * cognitive impairments limiting study participation

Keywords: sci diaphragm pacing respiratory impairment diaphragm stimulation
functional magnetic resonance imaging (fmri) of anosognosia in amnestic mild cognitive impairment (mci) and alzheimer's disease (ad)

Conditions: Anosognosia; Alzheimer's Disease; Mild Cognitive Impairment

Summary: this is a three year fmri study conducted at the university of wisconsin (uw) hospital and the william. s. middleton va hospital. this study is guided by the hypothesis that reduced fmri activity and connectivity cortical midline structures (i.e., medial frontal and ventral posterior cingulate cortex) are physiologic abnormalities that relate strongly to the compromised insight into cognitive deficits, or anosognosia, shown by a subset of individuals with amnestic mci (amci) and ad. further, the investigators hypothesize that these regional changes in fmri activity are predictive of faster progression from amci to ad.


Eligibility criteria:
inclusion criteria: * amnestic mci: 1. observation of memory decline by informant. 2. mini mental status exam (mmse) score between 24 and 30. 3. objective memory impairment on neuropsychological tests. 4. intact functional abilities, and 4) no diagnosis of dementia. * ad: 1. a diagnosis of probable ad according with the ninds-adrda and dsm-iv diagnostic criteria. 2. mmse score between 16 and 27. all ad patients will have capacity to provide informed consent as judged by the referring physician. exclusion criteria: * mri incompatibility; history of neurologic disease (including prior loss of consciousness of more than 10 minutes); prior neurosurgery; or chronic medical diseases (such as poorly controlled diabetes, renal disease, or poorly controlled hypertension). * excluded medications include neuroleptics, short or long acting nitrates, and warfarin. * other exclusions include: less than 10 yrs of education; hachinski scale of 4 or more; first language other than english; poor visual or auditory acuity; pregnancy.

Keywords: anosognosia fmri amnestic mci alzheimer anosognosia in ad and mci
study of the link between psychosocial treatments and the need of pharmacological treatments in children with attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder; Youths

Summary: the attention deficit and hyperactivity disorder (adhd) is a frequent disorder in children and adolescents. the diagnosis is clinical with the input of several informants (child, family, teachers, ...). adhd is a risk factor for academic difficulties, school dropout, social isolation, injury, oppositional behaviour. in school-age children and adolescents having moderate to high or persistent impairment despite psycho-educational support and environmental modification, the first-line treatment is methylphenidate. group or individual cognitive behavioural therapy for parents and/or children and adolescents is recommended for co-occurring disorders and persistent impairment. in france, the initiation of methylphenidate requires an annual hospital prescription by a paediatrician or psychiatrist, and a regular medical supervision (weight, heart rate, blood pressure, ...). at least once a year, the indication of methyphenidate needs to be re-evaluated and confirmed at the hospital. in case of lack of efficiency and/or poor tolerance, therapeutic alternatives including non-psychostimulants should be considered. a randomized controlled trial evaluated the dose of methylphenidate received over a period of 13 months. it was observed that the "combined treatment" group (methylphenidate + psychosocial treatments) received a lower average dose of methylphenidate than the "methylphenidate alone" group. these results are difficult to extrapolate to the general population, due to the study protocol (regular monitoring of adhd symptoms with the aim of total remission). for a global consideration of children's needs, it is important to better understand the interactions between these two therapeutic approaches. to participate in the study, parents will have to complete an online questionnaire. this questionnaire contains anamnestic data collection, questionnaires to assess adhd symptoms and parenting practices.


Eligibility criteria:
inclusion criteria: - children 6-18 years of age, diagnosed with adhd, treated with methylphenidate for at least 6 months. parents' online response between may and june 2020. exclusion criteria: - exclusion of respondants not caring for the child , refusal to participate

Keywords: adhd treatment with methylphenidate behavioral parent training
flow-synchronized nasal imv in preterm infants

Conditions: Premature Infant Disease; Respiratory Insufficiency

Summary: the use of non-invasive methods of respiratory support to reduce complications of prolonged invasive mechanical ventilation in preterm infants has increased. the most common mode is nasal intermittent mandatory ventilation (nimv). in nimv, the interval between mechanical breaths is fixed and is determined by the frequency dialed by the clinician. asynchrony between the infant's spontaneous breathing may exist since mechanical breaths delivered at fixed intervals can occur at different times over the inspiratory or expiratory phases of the infant's spontaneous breathing. synchronized-nimv is a mode similar to nimv where the ventilator cycle is delivered in synchrony with the infant's spontaneous inspiration. this has been achieved by using techniques to detect the infant's spontaneous inspiration. the advantages or disadvantages of synchronized compared to non-synchronized nimv remain to be determined. this study seeks to evaluate the effect of synchronized nimv versus non-synchronized nimv on ventilation and gas exchange in premature infants who require supplemental oxygen. the hypothesis is that the use of flow synchronized nasal intermittent mandatory ventilation (s-nimv) in comparison to non-synchronized nimv will improve ventilation and gas exchange and reduce breathing effort. the objective of the study is to compare the effect of flow synchronized-nimv to non-synchronized-nimv on tidal volume (vt), minute ventilation (ve), gas exchange, breathing effort, apnea and chest wall distortion in preterm neonates with lung disease.


Eligibility criteria:
inclusion criteria: * preterm infants of 30 or less weeks of gestational age * receiving nimv * requiring fi02 \> 0.21 to keep sp02 \> 90% * parental written informed consent exclusion criteria: * major congenital anomalies * proven sepsis within 72 hours of the study * hypotension requiring pressors within 72 hours of the study * pneumothorax or pneumomediastinum within 72 hours of the study * current suspected necrotizing enterocolitis, spontaneous perforation or severe abdominal distention

Keywords: nasal ventilation premature infants synchronized ventilation non-invasive respiratory support
choline supplementation in children with fetal alcohol spectrum disorders

Conditions: Fetal Alcohol Spectrum Disorders; Fetal Alcohol Syndrome; Partial Fetal Alcohol Syndrome; Alcohol-related Neurodevelopmental Disorder; Prenatal Alcohol Exposure

Summary: the purpose of this study is to determine whether choline supplementation can improve cognitive functioning of children with prenatal alcohol exposure.

despite the known damaging effects of alcohol on the developing fetus and the presence of warning labels on alcoholic beverages, many pregnant women continue to drink alcohol. the consequences include a range of physical, neurological, and behavioral effects referred to as fetal alcohol spectrum disorders (fasd). unfortunately, there are currently no comprehensive treatments for individuals with fasd. this pilot study will examine whether a nutritional intervention could reduce the severity of cognitive deficits associated with prenatal alcohol exposure. choline is an essential nutrient, necessary for brain and behavioral development. animal studies have shown that prenatal or early postnatal choline supplementation can lead to long-lasting cognitive enhancement. similarly, choline supplementation improves cognitive outcomes among rats exposed to alcohol during development, even when administered postnatally and after alcohol exposure has occurred. the present experiment translates these findings to a clinical population of individuals exposed to heavy prenatal alcohol exposure. subjects will be randomly assigned to receive daily choline supplementation or placebo control for a period of 6 weeks (approximately 20 subjects per group). performance on neuropsychological tasks that measure cognitive functioning will be measured prior to treatment and at 6 weeks. these data will provide important information regarding a potential nutritional intervention for fetal alcohol spectrum disorders.

Eligibility criteria:
inclusion criteria: * confirmed histories of prenatal alcohol exposure (by review of medical, legal, or social service records or maternal report, if available; information about levels and timing of exposure will be inquired, but not necessary for inclusion) * english as primary language exclusion criteria: * significant physical (e.g., uncorrected visual impairment, hemiparesis) or psychiatric (e.g., psychosis) disability that would prohibit participation * history of neurological condition (e.g., epilepsy)

Keywords: choline glycerophosphocholine choline alphoscerate fetal alcohol spectrum disorders fetal alcohol syndrome partial fetal alcohol syndrome alcohol-related neurodevelopmental disorder prenatal alcohol exposure fetal alcohol effects pregnancy complications alcohol-induced disorders alcohol-related disorders central nervous system agents therapeutic uses
attitudes towards deprescribing medications in cancer patients and impact of educational intervention by a clinical pharmacist

Conditions: Cancer Patients in Palliative Care with Chronic Use of Non-oncologic Medications

Summary: your participation in this study consists in responding to some questions from two questionnaires in romanian about how you feel about deprescribing, your treatment and how you understand medical information. after that, you'll receive a brochure and watch a video with some basic information about medications and your involvement in treatment decisions and in the next visit for your cancer treatment you will be asked to answer questions from one of the initial questionnaire.

cancer patients are susceptible to using a lot of medications, with an increased risk of drug-related problems that could lead to adverse reactions from oncological drugs, hospital admissions, deteriorated performance status and increased mortality. in time, some medications may no longer be efficient, may have adverse reactions or may lose their indication and need to be stopped or replaced. this process is named deprescribing and it's supervised by a health care professional. deprescribing can't be done without the implication of the patients, that's why it's important to investigate cancer patient's attitudes towards deprescribing non-oncologic medications in romanian patients using a validated questionnaire (rpatd). recent studies from romania showed a possible lack of health care literacy that could affect patients involvement in treatment decision. in this study, we will investigate health care literacy using a validated questionnaire in romanian (hls-eu-q16). in this study we will also investigate if an educational intervention (targeting patients involvement in treatment decision and mandatory, minimal information about efficacy of a treatment and its adverse reactions) conducted by a clinical pharmacist using a brochure and a video will improve their engagement and knowledge about drugs. impact of educational intervention will be investigated by applying the rpatd questionnaire before and after the intervention.

Eligibility criteria:
inclusion criteria: * cancer patients in palliative treatment * ecog 1-2 exclusion criteria: * cancer patients in curative treatment * ecog 3-4 * cognitive impairment

Keywords: palliative care cancer clinical pharmacist educational intervention rpatd